NCT04250805

Brief Summary

Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

January 30, 2020

Last Update Submit

January 30, 2024

Conditions

CancerFeeding Disorders

Keywords

CancerGastrostomyPercutaneous techniqueRadiological guidanceLidocaineRopivacainePain

Outcome Measures

Primary Outcomes (1)

  • Level of Pain

    Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt.

    24 hours

Secondary Outcomes (3)

  • Level of Anxiety and Depression

    10 days

  • Level of quality of life

    10 days

  • Level of satisfaction

    10 days

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance

Drug: Lidocaine

Lidocaine and Ropivacaine

EXPERIMENTAL

Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance

Drug: LidocaineDrug: Ropivacaine

Interventions

LidocaineDRUG

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

LidocaineLidocaine and Ropivacaine
RopivacaineDRUG

Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Lidocaine and Ropivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major patient;
  • Having an indication for placement of PRG (percutaneous radiological gastrostomy);
  • Patient hospitalized for a minimum of 24 hours post gastrostomy;
  • Pregnant or lactating woman;
  • Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
  • Not knowing how to read and / or write French;
  • Allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients;
  • Recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin);
  • Patient on beta blockers during the installation of PRG (Percutaneous Radiological Gastrostomy);
  • Indication of gastrostomy button placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

NeoplasmsFeeding and Eating DisordersPain

Interventions

LidocaineRopivacaine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersNeurologic Manifestations

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Guillaume Etievent, MD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

October 27, 2020

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)